SAN FRANCISCO, June 7 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals,
Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced
additional results from a study of patients with type 2 diabetes who were
unable to achieve glycemic control through diet and exercise alone and were
treated with either monotherapy (stand-alone) BYETTA(R) (exenatide)
injection taken twice daily or placebo. Study findings showed that patients
treated with monotherapy exenatide showed statistically significant
improvement in both A1C and weight loss with a lower incidence of nausea
than in previous exenatide studies. Exenatide is indicated as adjunctive
therapy to improve glycemic control in patients with type 2 diabetes
mellitus who are taking metformin, a sulfonylurea, a thiazolidinedione, a
combination of metformin and a sulfonylurea, or a combination of metformin
and a thiazolidinedione, but have not achieved adequate glycemic control.
These findings were presented at the 68th Annual Scientific Sessions of the
American Diabetes Association (ADA) in San Francisco.

In this 24-week randomized, double-blind, placebo-controlled, parallel
study of 232 drug-naive patients (N=77 exenatide 5 mcg, N=78 exenatide 10
mcg, N=77 placebo) with type 2 diabetes who were treated with 5 mcg and 10
mcg of exenatide as a monotherapy reduced their A1C (a measure of average
blood sugar over three months) by 0.7 percentage points and 0.9 percentage
points, respectively, from an average baseline A1C of 7.9 and 7.8 percent,
respectively. In the 5 mcg arm, 86 percent of study participants completed
the study and in the 10 mcg arm, 87 percent completed the study. Sixty
percent of the 5 mcg evaluable study participants and 61 percent of the 10
mcg evaluable study participants achieved or maintained an A1C of less than
or equal to 7 percent at study end, a common target for good glucose
control.

"Healthcare professionals and their patients with type 2 diabetes need
a variety of treatment options to successfully manage the disease," said
Jim Malone, M.D., Global Medical Director, Eli Lilly and Company. "These
data are robust and show the important glucose lowering properties of
BYETTA taken as monotherapy. If approved, this indication would give
physicians the option to prescribe exenatide as a stand-alone treatment,
which may allow for increased patient access to BYETTA."

This study was conducted following receipt of an approvable letter for
a monotherapy indication from the FDA in 2005. In addition to the clinical
studies included in the 2005 submission package, data from this study
address requests by the FDA as a result of that approvable letter.

There was an incidence of reported nausea in both the 5 mcg and 10 mcg
arms of 3 and 13 percent, respectively, which is a lower incidence than
what was observed in previous studies, where exenatide has been used in
combination with other diabetes therapies. There were no instances of
severe hypoglycemia. The overall incidence of hypoglycemia was similar to
that seen in studies where exenatide was used in conjunction with metformin
only.

Study Population

The 24-week, randomized study included 232 patients with type 2
diabetes who were not achieving adequate glucose control using diet and
exercise without previous use of antidiabetes agents. Study participants
were randomized to receive subcutaneous injections of placebo, 5 mcg
exenatide, or 10 mcg exenatide twice daily without taking any oral
antidiabetes agents. Patients randomized to 10 mcg exenatide received 5 mcg
injections for the first four weeks, and increased to 10 mcg injections for
the final 20 weeks.

About BYETTA(R) (exenatide) injection

BYETTA is the first and only FDA-approved incretin mimetic for the
treatment of type 2 diabetes. BYETTA exhibits many of the same effects as
the human incretin hormone glucagon like peptide-1 (GLP-1). GLP-1 improves
blood sugar after food intake through multiple effects that work in concert
on the stomach, liver, pancreas and brain. BYETTA is approved by the FDA
for use by people with type 2 diabetes who are unsuccessful at controlling
their blood sugar levels. BYETTA is an add-on therapy for people currently
using metformin, a sulfonylurea, or a thiazolidinedione. BYETTA provides
sustained A1C control, low incidence of hypoglycemia when used with
metformin or a thiazolidinedione, and progressive weight loss. BYETTA was
approved in April 2005 and has been used by approximately one million
patients since its introduction. For full prescribing information, visit
http://www.BYETTA.com.

About Diabetes

Diabetes affects more than 21 million in the United States and an
estimated 246 million adults worldwide.(1,2) Approximately 90-95 percent of
those affected have type 2 diabetes. Diabetes is the fifth leading cause of
death by disease in the United States and costs approximately $132 billion
per year in direct and indirect medical expenses.(3)

According to the Centers for Disease Control and Prevention's National
Health and Nutrition Examination Survey, approximately 60 percent of people
with diabetes do not achieve their target blood sugar levels with their
current treatment regimen.(4) In addition, 85 percent of type 2 diabetes
patients are overweight and 55 percent are considered obese.(5) Data
support that weight loss (even a modest amount) supports patients in their
efforts to achieve and sustain glycemic control.(6,7)

Important Safety Information for BYETTA

BYETTA improves glucose (blood sugar) control in adults with type 2
diabetes. It is used with metformin, a sulfonylurea, or a
thiazolidinedione. BYETTA is not a substitute for insulin in patients whose
diabetes requires insulin treatment. BYETTA is not recommended for use in
patients with severe problems digesting food or those who have severe
disease of the stomach or kidney.

When BYETTA is used with a medicine that contains a sulfonylurea,
hypoglycemia (low blood sugar) is a possible side effect. To reduce this
possibility, the dose of sulfonylurea medicine may need to be reduced while
using BYETTA. Other common side effects with BYETTA include nausea,
vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach.
Nausea is the most common side effect when first starting BYETTA, but
decreases over time in most patients.

If patients experience the following severe and persistent symptoms
(alone or in combination): abdominal pain, nausea, vomiting, or diarrhea,
they should talk to their healthcare provider because these symptoms could
be signs of serious medical conditions. BYETTA may reduce appetite, the
amount of food eaten, and body weight. No changes in dose are needed for
these side effects. These are not all of the side effects from use of
BYETTA. A healthcare provider should be consulted about any side effect
that is bothersome or does not go away.

Amylin Pharmaceuticals is a biopharmaceutical company committed to
improving lives through the discovery, development and commercialization of
innovative medicines. Amylin has developed and gained approval for two
first- in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate)
injection and BYETTA(R) (exenatide) injection. Amylin's research and
development activities leverage the company's expertise in metabolism to
develop potential therapies to treat diabetes and obesity. Amylin is
headquartered in San Diego, California with over 2,000 employees
nationwide. Further information about Amylin Pharmaceuticals is available
at http://www.amylin.com.

Through a long-standing commitment to diabetes care, Lilly provides
patients with breakthrough treatments that enable them to live longer,
healthier and fuller lives. Since 1923, Lilly has been the industry leader
in pioneering therapies to help healthcare professionals improve the lives
of people with diabetes, and research continues on innovative medicines to
address the unmet needs of patients. For more information about Lilly's
current diabetes products visit, http://www.lillydiabetes.com.

Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Indiana, Lilly provides answers - through medicines and
information - for some of the world's most urgent medical needs. Additional
information about Lilly is available at http://www.lilly.com.

This press release contains forward-looking statements about Amylin and
Lilly. Actual results could differ materially from those discussed or
implied in this press release due to a number of risks and uncertainties,
including the risk that BYETTA and the revenues generated from BYETTA may
be affected by competition; unexpected new data; technical issue; clinical
trials not confirming previous results; pre-clinical trials not predicting
future results; label expansion requests, including the FDA submission
referred to in this press release, not being submitted in a timely manner
or receiving regulatory approval; or manufacturing and supply issues. The
potential for BYETTA may also be affected by government and commercial
reimbursement and pricing decisions, the pace of market acceptance, or
scientific, regulatory and other issues and risks inherent in the
commercialization of pharmaceutical products. These and additional risks
and uncertainties are described more fully in Amylin and Lilly's most
recently filed SEC including their Quarterly Reports on Form 10-Q and
Annual Reports on Form 10-K. Amylin and Lilly undertake no duty to update
these forward-looking statements.

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